The LUNGevity Foundation and 41 stakeholders aim to reduce cancer patients' confusion about in vitro diagnostic testing by implementing two consistent umbrella terms.
Paired tumor/germline analysis is not routinely done in cancer care, but some labs are starting to report incidental germline findings alongside patient's tumor profiles.
Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.
The approval of its Omics Core assay for tumor-normal mutational profiling opens the door for payor reimbursement, which is key to reaching profitability, NantHealth said.
The embattled company saw its net loss narrow during the first quarter, in part due to a new policy of giving away fewer nonreimbursed GPS Cancer and Liquid GPS molecular test orders than in the past.
